EU Food Supplement Directive
- Definition of a food supplement (art 2)
‘food supplements’ means foodstuffs the purpose of which is to supplement the normal diet, and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities.
At this stage the Directive contains detailed rules only on vitamins and minerals, and their chemical forms included in the Annexes to the Directive. A report on other substances with a nutritional and physiological effect will be submitted by the Commission by July 2007.
Vitamins and minerals not included in the annexes may be sold in EU Member States at those States’ discretion until December 2009, provided those vitamins and mineral forms have already been in use in the EU and that the European Food Safety Authority has not given an unfavourable opinion to a scientific dossier on that substance.
- Maximum safety levels (article 5)
Maximum amounts of vitamins and minerals in food supplements still have to be set. To that effect the European Commission published a discussion paper mid 2006 asking stakeholders to address relevant questions.
The
risk management model that was developed by ERNA was included in the discussion paper. The ERNA response to this discussion paper can be found
here.
The maximum levels set by the Commission will take into account the upper tolerable intake levels established by the Scientific Committee on Food and later on by the European Food Safety Authority (EFSA) based on scientific risk assessment (include link), intake from other dietary sources and due account will be taken of reference intakes of vitamins and minerals.
- Labeling provisions (article 6, 7, 8, 9)
- Notification (article 10)
The Member States may require manufacturers to notify the authorities of products on the market.
Member States were required to bring into force national laws that comply with the Directive by 31 July 2003, and prohibit products that do not apply by 1 August 2005.